PumpKIN PreClinical

PumpKIN 临床前

• 批准号: 8241867
• 负责人: ROBERT JARVIK
• 金额: $ 253.1万
• 依托单位: JARVIK HEART, INC.
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-01-15 至 2014-01-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8241867
• 关键词: Adult; Animals; Annual Reports; Boston; Caliber; Cardiac; Ceramics; Child; Childhood; Clinical; Clinical Trials; Computer software; Conduct Clinical Trials; Contracts; Country; Development; Devices; Employee; Engineering; Enrollment; Europe; Evaluation; Funding; Future; Heart; Hemolysis; Human Engineering; Implant; Infant; Journals; Laboratory Animals; Life; Longitudinal Studies; Maryland; Measurement; Measures; Mechanics; Medical center; Membrane; Michigan; Microprocessor; Modeling; Motor; Multi-Institutional Clinical Trial; Newborn Infant; Operative Surgical Procedures; Output; Pacemakers; Patients; Pediatric Hospitals; Pennsylvania; Predisposition; Publishing; Pump; Reporting; Safety; Site; Speed; Sterilization; Surgeon; System; Techniques; Testing; Thrombus; Transplantation; United States National Institutes of Health; Universities; Validation; Ventricular; Washington; Welding; Work; base; blood pump; design; experience; feeding; hemodynamics; interest; operation; pre-clinical; programs; research study; seal

The infant size Jarvik 2000 heart is the smallest permanently implantable blood pump developed as part of the NIH Pediatric VAD Program, and to our knowledge, the smallest in the world. At only 10.5mm diameter, 5.2 cm long and 4cc in volume it is small enough to implant in the ventricular apex of 3.5 Kg. newborns yet it has flow capacity over 3L/min - sufficient output for children up to 25 Kg. Animal implants have shown that the pump remains free of thrombus and operates at low power without causing hemolysis. The pump represents a completed design, incorporating all of the requirements for a long term implant, including welded hermetic sealing of the motor stator and rotor magnet, miniature hermetic feed-throughs for the power cables, a very long life ceramic conical bearing design, and pacemaker type high flex life power cables from the external controller to the implanted blood pump. An advanced microprocessor based control system has just been completed, although only the software for the basic functions (speed setting, measured speed, battery remaining, power, display function management via membrane switches) is presently available. This permits basic operation but does not yet implement some of the more advanced functions planned for the future. Jarvik Heart, Inc. is a small company of only 36 employees, but has successfully conducted clinical trials with the adult model Jarvik 2000, has received CE mark approval in Europe, has completed a 63 patient Pilot IDE study, and enrolled 100 of 150 patients in the IDE pivotal bridge to transplant study. The company thus has sufficient experience to sponsor an IDE clinical trial of the infant Jarvik 2000 and to obtain HUD designation and HDE approval. Over the course of the present five year contract we have collaborated successfully with Dr. Griffith's animal laboratory at the University of Maryland, and they will be a major subcontractor if our proposal is funded. Dr. Bartley Griffith, the Co-PI together with Dr. Jarvik, has extensive cardiac surgical experience with numerous mechanical circulatory support devices, and is a pediatric cardiac surgeon as well as an adult surgeon. We have established relationships with major pediatric cardiac surgical centers that have expressed interest in joining an multi-center Clinical Trial to evaluate the pediatric Jarvik2000. These include Dr. William Gaynor (University of Pennsylvania), Dr. Pedro del Nido (Boston Children's Hospital), Dr. Richard Jonas (Washington National Pediatric Center), Dr. Ed Bovie (University of Michigan) and Dr. Marcelo Cardarelli, Dr. Duke Cameron, and Dr. Luca Vricella (University of Maryland & Johns Hopkins). The PIs from each site will comprise an advisory group for the development of our IDE application, and will advise us concerning other clinical matters including surgical technique and patient management.

婴儿尺寸的Jarvik 2000心脏是作为NIH儿科VAD计划的一部分开发的最小的永久植入式血泵，据我们所知，是世界上最小的。直径仅为10.5 mm，长5.2 cm，体积为4 cc，足以植入3.5 Kg的心室尖部。新生儿，但它有超过3升/分钟的流量-足够的输出高达25公斤的儿童。动物植入物表明，泵保持无血栓，并在低功率下运行，不会引起溶血。泵代表完整的设计，包含长期植入物的所有要求，包括电机定子和转子磁体的焊接密封、电源电缆的微型密封馈电电缆、极长寿命陶瓷锥形轴承设计以及从外部控制器到植入血泵的起搏器型高弯曲寿命电源电缆。一个先进的基于微处理器的控制系统刚刚完成，尽管目前只有基本功能（速度设置、测量速度、电池剩余量、电源、通过薄膜开关的显示功能管理）的软件可用。这允许基本操作，但尚未实现计划在未来实现的一些更高级的功能。 贾维克心脏公司是一家只有36名员工的小公司，但已经成功地用成人模型Jarvik 2000进行了临床试验，在欧洲获得了CE认证，完成了63例患者的试验性IDE研究，并在IDE关键桥移植研究中招募了150例患者中的100例。因此，该公司有足够的经验申办婴儿Jarvik 2000的IDE临床试验，并获得HUD认定和HDE批准。在目前的五年合同期间，我们与马里兰州大学格里菲斯博士的动物实验室成功合作，如果我们的提案得到资助，他们将成为主要分包商。Bartley Griffith博士是Jarvik博士的共同主要研究者，他在使用多种机械循环支持器械方面拥有丰富的心脏外科经验，是一名儿科心脏外科医生和一名成人外科医生。我们已经与主要的儿科心脏外科中心建立了关系，这些中心表示有兴趣参加多中心临床试验，以评估儿科Jarvik 2000。其中包括William Gaynor博士（宾夕法尼亚大学）、Pedro del Nido博士（波士顿儿童医院）、Richard Jonas博士（华盛顿国家儿科中心）、艾德·博维博士（密歇根大学）和Marcelo Cardarelli博士、杜克博士、卡梅隆博士和Luca Vricella博士（马里兰州和约翰霍普金斯大学）。每个研究中心的PI将组成一个咨询小组，负责开发我们的IDE申请，并就其他临床问题（包括手术技术和患者管理）向我们提供建议。